Licensing process explained

GMO Licensing

Since 1995, the EPA is the Competent Authority in Ireland for the implementation of the GMO Regulations on the contained use, the deliberate release and the transboundary movement of GMOs (since 2004) into the environment.

Any person or organisation utilising a GMO requires prior consent from the EPA in order to do so. The EPA is responsible for the licensing of GMO activity both for what’s called ‘contained use’ (usually in colleges/ industry /hospital laboratories) or deliberate release of a GMO for purposes other than placing on the market (field trials and/or clinical trials for purposes of R&D) and for the placing on the market of GMOs as or in products. It also has remit for transboundary movement of GMOs.

What is Contained Use?

Contained use relates to the use of GMMs/GMOs under containment i.e. the employment of physical barriers or a combination of physical barriers together with chemical (disinfectants) and/or biological barriers (specific nutritional requirements), to limit contact between the GMM/GMO and the environment and the general public. In Ireland the contained use of GMMs/GMOs is largely carried out in research laboratories in universities, hospitals, state laboratories and in biopharmaceutical companies. GMMs may be classified as Class 1, Class 2, Class 3 or Class 4, based on the risk the GMM poses to human, animal, plant health or the environment as determined by a Risk Assessment. Class 1 GMMs pose no or negligible risk, Class 2 GMMs pose a low risk, Class 3 GMMs pose a moderate risk while Class 4 GMMs pose a high risk. As the risk posed by the GMM increases from Class 1 to Class 4, more stringent containment measures are required to be put in place. GM plants and GM animals are not subject to the same classification system they are however required to be similarly contained.

What is Deliberate Release?

After GM products have undergone research and development in contained use settings the next stage is their release into the environment without the provision of any physical containment. The legislation defines Deliberate Release as ‘any intentional introduction into the environment of a GMO or a combination of GMOs for which no specific containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment’.

The legislation covering this, EU Directive 2001/18/EC (repealing Directive 90/220/EEC on the deliberate release of GMOs into the environment) - was transposed into Irish Law as GMO (Deliberate Release) Regulations, S.I. No. 500 in 2003 – refer to section on Legislation

Two types of Deliberate Release are covered by Directive 2001/18/EC

Part B Deliberate release

This involves releasing a GMO into the environment for purposes of R&D e.g. a field trial of GM crops or a hospital clinical trial where GM based therapies are administered to patients.

Part C Deliberate Release

This involves placing products containing or consisting of GMOs on the market for payment or free of charge.

What is Transboundary movement of GMOs?

Persons intending to export GMOs for purposes of deliberate release into the environment, must notify in writing, the national competent authority of the country of import, prior to the transboundary movement taking place.

A person wishing to challenge the validity of an EPA decision may do so by way of judicial review only. The validity of a decision taken by the EPA may only be questioned by making an application for Judicial Review under Order 84 of the Rules of the Superior Courts (as amended). The Rules of the Superior Courts and all relevant amendments can be found at www.courts.ie or www.irishstatutebook.ie

Order 84 rule 21(1) of the Rules of the Superior Courts (as amended) provides that any application for judicial review must be made within three months of the decision of the EPA. Order 84 rule 21(3) allows the High Court extend this period in limited circumstances.

Disclaimer: The above is intended for information purposes. It does not purport to be a legal interpretation of the relevant provisions and it would be advisable for persons contemplating judicial review proceedings to seek independent legal advice.